- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00162799
Efficacy Pilot Study of Triflusal in the Attenuation of Insulin Resistance in Human Obesity
June 22, 2006 updated by: J. Uriach and Company
Phase IIa Study of Triflusal in the Attenuation of Insulin Resistance in Men and Woman With Obesity
To explore the efficacy of triflusal in the attenuation of insulin resistance in human obesity.
Triflusal is a salicylate compound approved in several countries as antithrombotic agent (antiplatelet).
The hypothesis is to explore if there is a reduction of obesity-induced insulin resistance by triflusal.
Study Overview
Detailed Description
Double-blind, randomized, cross-over (three periods) with two dose levels of triflusal, placebo-controlled.
Interventions: treatment periods Triflusal 600 mg/d, 15 days Triflusal 900 mg/d , 15 days placebo, 15 days
Washout period: 30 days
Study Type
Interventional
Enrollment
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Girona, Spain, 17007
- Unitat de Diabetologia, Endocrinologia y Nutrición Hosp Josep Trueta
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
33 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 35 to 60 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Increase of insulin sensitivity in apparently healthy men and woman evaluate by means of i.v. glucose tolerance test (PTEVGMR).
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Secondary Outcome Measures
Outcome Measure |
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Reduction antropometric measures associated with insulin resistance and arterial hypertension.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jose Manuel Fernández del Real, Dr, Unidad Diabetología. Serv Endocrino Hosp Josep Trueta
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Study Completion
December 1, 2004
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 13, 2005
Study Record Updates
Last Update Posted (Estimate)
June 23, 2006
Last Update Submitted That Met QC Criteria
June 22, 2006
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICO5TRI/2/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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